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Fortress Biotech (FBIO)
NASDAQ:FBIO

Fortress Biotech (FBIO) AI Stock Analysis

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FBIO

Fortress Biotech

(NASDAQ:FBIO)

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Neutral 51 (OpenAI - 4o)
Rating:51Neutral
Price Target:
$3.00
▲(2.39% Upside)
The overall stock score reflects significant financial challenges, including declining revenues and high leverage, which are major concerns. While technical indicators show some positive momentum, and the earnings call provided optimistic guidance, the negative valuation metrics and regulatory challenges weigh heavily on the stock's outlook.
Positive Factors
Successful Product Launch
The strong performance of EMROSI indicates successful market penetration and potential for sustained revenue growth, enhancing the company's competitive position in the dermatology sector.
Market Access Achievements
Broad market access for EMROSI suggests strong payer strategy execution, which can lead to increased sales and a stable revenue stream as coverage expands.
NDA Resubmission
The resubmission of the NDA for CUTX-101 could lead to new revenue streams, enhancing the company's product portfolio and addressing unmet medical needs in the rare disease sector.
Negative Factors
Declining Revenues
Declining revenues reflect challenges in maintaining sales momentum, which could impact the company's ability to invest in R&D and sustain long-term growth.
High Leverage
High leverage poses risks to financial stability, limiting the company's ability to invest in growth opportunities and increasing vulnerability to economic downturns.
Regulatory Challenges
Regulatory challenges can delay product launches and impact revenue timelines, affecting the company's strategic positioning and investor confidence.

Fortress Biotech (FBIO) vs. SPDR S&P 500 ETF (SPY)

Fortress Biotech Business Overview & Revenue Model

Company DescriptionFortress Biotech, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative drugs and therapies for a variety of medical conditions. The company operates through a diverse portfolio of subsidiaries and partnerships, primarily in the oncology and rare disease sectors. Fortress Biotech's core products and services include the development of novel therapeutics, with an emphasis on biologics and small molecules designed to address unmet medical needs.
How the Company Makes MoneyFortress Biotech generates revenue through multiple streams, primarily from the commercialization of its proprietary drug candidates and through collaborations with other pharmaceutical companies. The company earns revenue from licensing agreements, where they partner with larger pharmaceutical firms to develop and market their products, receiving milestone payments and royalties based on sales. Additionally, Fortress Biotech receives funding through equity investments and grants aimed at supporting research and development efforts. Significant partnerships with established pharmaceutical companies enhance their financial stability and broaden their market reach, contributing to their overall earnings.

Fortress Biotech Earnings Call Summary

Earnings Call Date:Nov 14, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 26, 2026
Earnings Call Sentiment Positive
The earnings call highlighted strong revenue growth driven by the successful launch of EMROSI, improved EBITDA, and expanding prescriber base. However, challenges remain with the decline in legacy product revenues and delays in health plan formulary adoption for EMROSI. Despite these issues, the company is optimistic about EMROSI's potential and future revenue growth.
Q3-2025 Updates
Positive Updates
Significant Revenue Growth
Journey Medical reported a 21% year-over-year revenue growth for Q3 2025, reaching $17.6 million compared to $14.9 million in Q3 2024.
EMROSI's Strong Performance
EMROSI contributed $4.9 million to the top line in Q3, an increase of 75% from Q2, with total prescription growth of approximately 146%.
Positive EBITDA Trends
Non-GAAP EBITDA improved by $500,000 year-over-year, with positive adjusted EBITDA of $1.7 million for Q3 2025, compared to $300,000 in Q3 2024.
Increased Prescriber Base for EMROSI
The number of unique EMROSI prescribers increased by approximately 50% to over 2,700, indicating a strong adoption among dermatologists.
Market Access Achievements
Over 100 million of the 187 million commercial lives currently have access to EMROSI, with plans to contract with the remaining major GPO early next year.
Negative Updates
Decline in Legacy Product Revenues
Revenue for legacy products like Qbrexza, Accutane, Amzeeq, and Zilxi declined by 16% year-over-year due to generic competition impacting Accutane.
Slight Decrease in Gross Margin
Gross margin decreased to 67.4% in Q3 2025 from 69.4% in the same period last year, primarily due to product mix changes.
Challenges with Health Plan Formulary Adoption
EMROSI's downstream health plan formulary adoption is taking time, impacting immediate coverage and increasing reliance on the co-pay assistance program.
Company Guidance
During Journey Medical's third-quarter 2025 earnings call, the company provided guidance highlighting a strong performance and optimistic outlook, driven by the successful launch of EMROSI, their oral treatment for rosacea. The company reported a 21% year-over-year revenue growth, with EMROSI contributing $4.9 million in Q3, marking a 75% increase from Q2. Total revenues reached $17.6 million, supported by a gross margin improvement from 63.5% in Q1 to 67.4% in Q3. The company observed a 146% increase in EMROSI prescriptions, totaling 18,198 in Q3, compared to 7,394 in Q2. Operating expenses increased by 9%, while SG&A expenses rose by 6% year-over-year, reflecting activities tied to the EMROSI launch. Non-GAAP adjusted EBITDA improved to $1.7 million, with the expectation of becoming sustainably EBITDA positive in Q4. Journey Medical also mentioned their payer strategy progress, with over 100 million of the 187 million commercial lives having access to EMROSI. The company anticipates peak annual net sales of over $200 million in the U.S. and over $300 million globally for EMROSI.

Fortress Biotech Financial Statement Overview

Summary
Fortress Biotech is facing financial instability with declining revenues, persistent losses, and high leverage. The company shows negative profitability metrics and potential liquidity risks due to high debt levels. Cash flows are insufficient to cover operational needs, raising concerns about sustainability without external financing.
Income Statement
30
Negative
Fortress Biotech has experienced a challenging financial period with declining revenues from 2023 to 2024, and persistent net losses. The gross profit margin remains positive at approximately 100% due to negligible cost of goods sold, but the company faces a negative EBIT and EBITDA margin, indicating operational inefficiencies. The net profit margin is significantly negative, reflecting high net losses relative to total revenue. Revenue growth was negative in the latest year, indicating a contraction in sales.
Balance Sheet
40
Negative
The balance sheet shows high leverage with a debt-to-equity ratio indicating significant reliance on debt financing. Stockholders' equity has decreased over time, impacting the equity ratio negatively. The return on equity is negative due to continuous net losses, suggesting poor return on shareholders' investments. The current debt levels could pose a risk if profitability does not improve.
Cash Flow
25
Negative
The cash flow analysis reveals negative operating cash flows, indicating that the company is not generating sufficient cash from operations to cover its expenses. Free cash flow is also negative, pointing to challenges in creating value for shareholders. The operating cash flow to net income ratio is unfavorable due to significant cash outflows and net losses.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue62.30M57.67M84.51M75.74M68.79M45.60M
Gross Profit41.01M36.80M61.62M44.97M36.71M31.00M
EBITDA-38.77M-104.49M-135.72M-193.69M-146.17M-87.82M
Net Income3.99M-46.00M-60.64M-86.58M-64.70M-46.53M
Balance Sheet
Total Assets181.41M144.22M167.53M294.30M396.50M333.41M
Cash, Cash Equivalents and Short-Term Investments86.22M57.26M80.93M178.27M305.74M233.35M
Total Debt68.29M75.96M88.59M127.34M74.98M89.08M
Total Liabilities116.22M145.87M165.94M244.28M170.63M136.41M
Stockholders Equity55.86M22.74M22.54M41.72M108.67M100.34M
Cash Flow
Free Cash Flow-66.14M-95.19M-136.32M-182.46M-132.89M-90.85M
Operating Cash Flow-66.14M-80.19M-128.22M-179.40M-116.54M-83.68M
Investing Cash Flow-4.88M-15.00M-2.10M-22.93M40.51M-7.16M
Financing Cash Flow97.54M70.64M32.74M75.32M148.99M172.41M

Fortress Biotech Technical Analysis

Technical Analysis Sentiment
Positive
Last Price2.93
Price Trends
50DMA
2.69
Positive
100DMA
2.71
Positive
200DMA
2.23
Positive
Market Momentum
MACD
0.07
Negative
RSI
59.70
Neutral
STOCH
88.28
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For FBIO, the sentiment is Positive. The current price of 2.93 is above the 20-day moving average (MA) of 2.73, above the 50-day MA of 2.69, and above the 200-day MA of 2.23, indicating a bullish trend. The MACD of 0.07 indicates Negative momentum. The RSI at 59.70 is Neutral, neither overbought nor oversold. The STOCH value of 88.28 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for FBIO.

Fortress Biotech Risk Analysis

Fortress Biotech disclosed 64 risk factors in its most recent earnings report. Fortress Biotech reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Fortress Biotech Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
$92.25M-1.26-49.78%-82.16%14.58%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$90.94M-10.9510.35%-0.32%94.05%
44
Neutral
$77.94M-2.03-90.24%-90.43%-382.07%
28
Underperform
$133.89M-1.92-102.47%66.05%
27
Underperform
$50.98M-0.65-328.04%42.29%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
FBIO
Fortress Biotech
3.32
1.47
79.46%
CVM
Cel-Sci
6.00
-13.50
-69.23%
XBIT
XBiotech
2.40
-4.52
-65.32%
EQ
Equillium
1.22
0.58
90.62%
RPTX
Repare Therapeutics
2.14
0.54
33.75%
UNCY
Unicycive Therapeutics
5.88
-1.12
-16.00%

Fortress Biotech Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
Fortress Biotech’s Subsidiary Resubmits NDA for CUTX-101
Positive
Nov 17, 2025

On November 14, 2025, Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, resubmitted the NDA for CUTX-101 to the FDA, a treatment for Menkes disease in pediatric patients. Cyprium retains ownership of any Priority Review Voucher from the NDA approval and stands to gain royalties and up to $129 million in development and sales milestones.

Product-Related AnnouncementsRegulatory Filings and Compliance
Fortress Biotech Receives FDA Response on CUTX-101
Negative
Oct 1, 2025

On October 1, 2025, Fortress Biotech, Inc. announced that the U.S. Food and Drug Administration issued a complete response letter for their product CUTX-101 (copper histidinate). This development may impact the company’s operations and its positioning within the pharmaceutical industry, as regulatory feedback can influence product timelines and stakeholder expectations.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Dec 09, 2025